US11224474B2 - System for managing high impedance changes in a non-thermal ablation system for BPH - Google Patents

Abstract

A protection circuit for a direct-current (DC) ablation prostate therapy system. The protection circuit is selectively coupled to a power source that provides DC constant current to a plurality of electrodes in a catheter configured to deliver DC ablation therapy to prostate tissue. The protection circuit is controlled by a controller and a switching circuit to buffer energy from the power source in response to a monitoring circuit that monitors at least one parameter of the DC ablation therapy, such as voltage or impedance. The controller is configured to selectively activate the switching circuit based on the monitoring circuit detecting an undesirable increase in the energy delivered for the DC ablation therapy.

Description

RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No. 62/636,636 filed Feb. 28, 2018, which is hereby fully incorporated herein by reference.

TECHNICAL FIELD

Embodiments generally relate to circuit protection for electrical systems, and more particularly to an overload protection circuit for monitoring high impedance changes in a non-thermal DC ablation system for prostate treatment.

BACKGROUND

Benign prostatic hyperplasia (BPH) is a common ailment among older men in which the prostate gland becomes enlarged. As the prostate enlarges, it can compress the urethra which in turn can cause extreme discomforts such as excessive urination, uncontrollable urination, incomplete emptying of the bladder, weak urine streams, or painful or bloody urination. Currently, there are various treatment options available for BPH. The level of treatment, however, can vary relative to the extent of discomfort or symptoms experienced. For example, such treatment could include lifestyle changes, drug therapy, non-surgical procedures, or surgical procedures. Surgical treatments of BPH may or may not be minimally invasive. For the surgical methods, access to the prostate may be via the urethra, the perineum, or other route.

Non-minimally invasive surgical treatments include Trans Urethral Resection of the Prostate (TURP). Conducted in an operating room under general or spinal anesthetic, a probe is passed through the urethra which scrapes away prostate tissue causing the blockage. Side effects may include retrograde ejaculation, impotence, and a repeat of the procedure if the blockage regrows.

Minimally invasive surgical treatments usually offer the incentives of less pain, faster recovery, lower costs, and use of local anesthesia and a mild sedative. In general, minimally invasive surgical treatments destroy prostate tissue through one of various mechanisms. The destroyed prostate tissue may be reabsorbed by the body and/or discharged into the urine over a period of time. Minimally-invasive surgical treatment options include generation of heat, freezing, chemical means, ultrasound, and non-thermal ablation to destroy prostate tissue. Examples of non-thermal ablation therapies and systems for treatment of BPH are described in U.S. Pat. Nos. 9,211,155 and 9,597,145, and U.S. Publ. Appl. Nos. 2010/0049192 and 2011/0106072, all of which are commonly owned by the assignee of the present application, and the disclosures of each of which are hereby incorporated by reference.

While providing advantages over conventional surgical treatments for BPH, minimally invasive surgical treatments have other issues that must be addressed. Care must be taken to avoid inadvertent nerve stimulation during minimally invasive treatment. For non-thermal ablation, for example, gas bubbles can form within the prostate tissue, thereby inducing voltage spikes which cause temporary unpleasant sensations to occur within patients. It would be desirable to provide improvements to non-thermal BPH treatment systems that could address these issues.

SUMMARY

Embodiments are directed to systems for controlling impedance swings for a DC ablation non-thermal BPH therapy system that delivers an essentially constant current to electrodes inside the prostate tissue to be removed.

There are two issues that occur with present DC ablation systems involving impedance increases. First, a gas bubble can largely enclose an electrode leading to a sudden short term impedance rise due to the nonconductance of the gas. Second, the tissue near the electrode can become desiccated leading to a gradual increase in impedance. In cases of the first issue, the sudden increase in impedance leads to a rapid voltage increase which can be painful to the patient. In cases of the second issue, the increased impedance reduces the effectiveness of the process by reducing or eliminating the current.

In various embodiments, a protection circuit is provided as part of a DC ablation non-thermal BPH therapy system and includes a power source configured to supply power to the circuit and an overload protection device configured to limit the peak voltage. A capacitor circuit is used to prevent sudden voltage spikes.

In certain embodiments, the protection circuit further includes a switching circuit configured to selectively control a supply path from the power source and the overload protection device. The protection circuit may also include a monitoring circuit comprising a reference unit, wherein the reference unit is configured to provide a reference signal. The protection circuit may further include a controller coupled to the monitoring circuit, wherein the controller is configured to activate the switching circuit based on the reference signal.

In the case of gradual impedance rises from desiccation, the protection circuitry may be configured to modify the pathways for current delivery for the non-thermal BPH therapy.

Some embodiments are directed to a method of restricting excess voltage via a protection circuit. The method generally includes receiving a reference signal characterizing an event of the protection circuit, enabling an overload protection device, and selectively utilizing the overload protection device.

An embodiment is directed to a direct current (DC) prostate ablation therapy system including: a catheter; a power source; an overload protection device; a monitoring circuit; a switching circuit; and a controller. The catheter includes a plurality of electrodes configured to deliver a DC ablation therapy to prostate tissue. The power source is configured to supply a DC current to the plurality of electrodes. The overload protection device is configured to buffer energy from the power source. The monitoring circuit is configured to monitor a voltage of the DC ablation therapy. The switching circuit is configured to selectively control a path of the DC current from the power source to the plurality of electrodes and the overload protection device. The controller is configured to selectively activate the switching circuit in response to the monitoring circuit detecting an undesirable increase in the voltage delivered for the DC ablation therapy.

In certain embodiments, the power source is configured to selectively supply the DC current as a constant current of between 10 to 50 mA of direct current.

In some embodiments, the overload protection device comprises at least one capacitor.

In some embodiments, each of the plurality of electrodes comprises at least one anode and at least one cathode. In some cases, each anode of each of the plurality of electrodes is electrically coupled to the power source via the switching circuit.

An embodiment is directed to a direct current (DC) prostate ablation therapy system including: a catheter; a power source; an overload protection device; a monitoring circuit; a switching circuit; and a controller. The catheter includes a plurality of electrodes configured to deliver a DC ablation therapy to prostate tissue. The power source is configured to supply a DC current to the plurality of electrodes. The overload protection device is configured to buffer energy from the power source. The monitoring circuit is configured to monitor an impedance of the DC ablation therapy. The switching circuit is configured to selectively control a path of the DC current from the power source to the plurality of electrodes and the overload protection device. The controller is configured to selectively activate the switching circuit in response to the monitoring circuit detecting an undesirable change in the impedance for the DC ablation therapy.

An embodiment is directed to a direct current (DC) prostate ablation therapy system including: a catheter; a power source; an overload protection device; a monitoring circuit; a switching circuit; and a controller. The catheter includes a plurality of electrodes configured to deliver a DC ablation therapy to prostate tissue. The power source is configured to supply a DC current to the plurality of electrodes. The overload protection device is configured to buffer energy from the power source. The monitoring circuit is configured to monitor a parameter of the DC ablation therapy. The switching circuit is configured to selectively control a path of the DC current from the power source to the plurality of electrodes and the overload protection device. The controller is configured to selectively activate the switching circuit in response to the monitoring circuit detecting a change in the parameter for the DC ablation therapy indicative of an undesirable increase in an energy being delivered by the DC ablation therapy.

The above summary is not intended to describe each illustrated embodiment or every implementation of the present invention. The detailed description and claims that follow more particularly exemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a system for treating tissue, according to an embodiment;

FIG. 2 shows a generator circuit, according to an embodiment with overvoltage protection;

FIG. 3A shows a schematic diagram of an overload protection device, according to a capacitor embodiment;

FIG. 3B shows a capacitor embodiment;

FIG. 4A shows a voltage spike with a gas bubble, according to an embodiment;

FIG. 4B shows a voltage spike with a gas bubble being reduced with the capacitor embodiment;

FIG. 5A shows two cathodes in parallel and two anodes in parallel and the associated treatment zones with moderate resistance, according to an embodiment; and

FIG. 5B shows an electrical diagram of FIG. 4A, according to an embodiment.

While embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring to FIG. 1, an ablation therapy system comprising a load protection circuit is depicted, according to an embodiment. As shown, system 100 includes a generator 102, electrodes 108, and a catheter 104, which is electrically coupled to generator 102 via cable 160. The catheter 104 may be inserted in the body to a desired location for tissue treatment. Once positioned, the electrodes 108 may be deployed through the catheter 104, while the position of the catheter 104 is maintained utilizing a fixation element. To treat tissue, generator 102 provides power to electrodes 108, which then apply a DC current to a treatment area of the tissue. The tissue is thus treated by DC ablation in a non-thermal manner. As illustrated, the electrodes 108 deploy outwardly from the catheter 104. Such outward deployment may be, for example, radial or may be linear. Generally, the electrodes 108 may be coupled to the catheter 104 or to a support structure in the catheter 104. The electrodes 108 further are configured to resist corrosion. In some embodiments, the electrodes 108 may comprise a Nitinol wire with a corrosion resistant coating. The corrosion resistant coating may be, for example, platinum or platinum-iridium. Additionally, as will be discussed in further detail with reference to FIG. 2, generator 102 comprises a load protection circuit 206, to detect and manage increases in impedance at the electrodes that can be caused by gas bubble formations at the surface of electrodes 108.

In FIG. 2, a block diagram of a generator circuit 200 is shown according to an embodiment. In embodiments, generator circuit 200 can comprise a power source 202, a controller 204, and a load protection circuit 206 operably coupled to drive an electrode load circuit 208. Power source 202 can comprise a direct current (DC) power source or an alternating current (AC) power source coupled to a converter that converts the AC power to DC power. Controller 204, which is electrically coupled to power source 202 and load protection circuit 206, can comprise analog circuitry, a microprocessor, a field programmable gate array, a programmable logic controller (PLC), and/or other suitable processing components in various embodiments.

In embodiments, load protection circuit 206 can comprise a monitoring circuit 210, a switching circuit 212, and an overload protection device 214 (or other buffer device configured to provide buffer energy to the circuit), which act together to monitor and protect against high impedance load conditions that can arise during treatment. For example, during treatment, as charge is delivered to the electrodes 108, gas formation at the electrode surface or local dehydration, thus leading to increased impedances at the electrode/tissue interface. Monitoring circuit 210 is connected to the electrode load circuit 208 to detect the conditions of load and generate a detection signal VL based on the load condition. In one embodiment, monitoring circuit 210 can be configured to detect the output voltage (V_OUT) of the electrical load circuit 208, while in other embodiments it can be configured to detect load impedance. In still other embodiments, monitoring circuit 210 can be configured to detect other parameters related to the load current. In embodiments, monitoring circuit 210 can comprise a comparator that compares the output voltage with a predetermined threshold voltage, and generates a control signal to controller 204 based upon the measured condition. For example, when the monitoring circuit 210 detects that the output voltage is above the predetermined threshold (e.g., if gas bubbles have formed at the electrode surface or the treated tissue has become dehydrated), the monitoring circuit 210 sends a control signal to the controller 204 to activate the switching circuit 212. In various embodiments, the comparator can include an operational amplifier, a multiplier, a subtractor, a digital microprocessor, or other suitable detection devices. Additionally, circuit 200 can comprise two or more comparator circuits in other embodiments.

As depicted, monitoring circuit 210 can be coupled to an output of electrode load circuit 208 and an input of switching circuit 212. In embodiments, monitoring circuit 210 can comprise a comparator or other suitable detection device to monitor high impedance conditions at the electrode load circuit 208. In some embodiments, monitoring circuit 210 may further comprise a filtering circuit having resistive-capacitive elements to stabilize the output signal received by load circuit 208.

Switching circuit 212 selectively enables and disables power flow to overload protection device 214 (i.e. buffer) and load circuit 208 based on an output signal of monitoring circuit 210, which generates an overload signal in response to an overload condition. In some embodiments, switching circuit 212 can comprise at least one switch 220 as shown in FIG. 3A. The at least one switch 220 may include, for example, metal-oxide-semiconductor field-effect-transistors (MOSFETs), insulated-gate bipolar transistors (IGBTs), gallium arsenide field-effect transistors (GaAsFETs), Gallium Nitride transistors (GaNFETs), bipolar junction transistors (BJTs), or other suitable active devices. An output of switching circuit 212 is coupled to an input terminal of overload protection device 214 and operates to activate device 214 in response to a detected increase in impedance. In one embodiment, overload protection device 214 can comprise a capacitor 240 coupled in parallel to power source 202 (see FIG. 3A). In particular, switching circuit 212 couples capacitor 240 to power source 202 in a charging position for charging the capacitor, and to an open discharging position for discharging capacitor 240. Those of skill in the art will understand that the specific type and values of capacitor 240 and power source 202 may vary according to design and specification. For example, in various embodiments, capacitor 240 can be sized between approximately 250 μF to 125 mF. In some embodiments, a filter circuit including resistive-capacitive elements may be incorporated into the protection circuit to reduce the electrical noise at the output.

Steady state DC voltage is generally not painful like AC voltage stimulate is as the use of DC voltage tends to not stimulate nerves. However, a sudden increase or decrease in a DC voltage can be painful. Dalziel C F, Massoglia F P, “Let-go currents and voltages,” Transactions of the American Institute of Electrical Engineers, Part II: Applications and Industry. 1956; 75(2):49-56.

FIG. 3B shows the preferred embodiment in which two electrolytic capacitors are connected in series with back biased diodes and anti-parallel configuration. This allows the use of large capacitance values and positive and negative voltages.

$\Delta V=I\frac{\Delta t}{C}$ $C=I\frac{\Delta t}{\Delta V}$

A typical ablation current is 25 mA and the duration of a gas bubble is 100 ms-10 s. In order to limit the maximum voltage increase to 2 volts the capacitance values will be between:

$1250\mathrm{\mu F}=\frac{25\mathrm{mA}·100\mathrm{<figure-callout\; id="2"\; label="ms"\; filenames="US11224474-20220118-D00005.png"\; state="\{\{state\}\}">ms</figure-callout>}}{2V}$ $\mathrm{and}$ $125\mathrm{mF}=\frac{25\mathrm{mA}·10\mathrm{<figure-callout\; id="2"\; label="s"\; filenames="US11224474-20220118-D00005.png"\; state="\{\{state\}\}">s</figure-callout>}}{2V}$

Because the primary factor for the pain is dV/dt, even smaller capacitors may be helpful for reducing the pain. To reduce the dV/dt below 100 volts per second, a capacitor of 250 μF will suffice.

FIG. 4A shows a typical voltage being delivered during DC ablation with a sudden increase during gas bubble formation. Since the conventional circuitry delivers a constant current, this voltage will be proportional to the impedance. If the impedance suddenly jumps to a very high value then the output voltage will go to the maximum available from the conventional circuitry.

FIG. 4B shows the output voltage being delivered during DC ablation with a smaller and slower increase during gas bubble formation with the instant invention.

In other embodiments, referring now to FIGS. 5A and 5B, protection circuit 206 can comprise a series of electrodes electrically coupled in parallel. For example, as shown in FIGS. 5A and 5B, at least one anode pair and at least one cathode pair may be provided in parallel. FIG. 5A illustrates a first anode 422, a second anode 426, a first cathode 420, and a second cathode 424. Although two anodes and two cathodes are illustrated in FIGS. 5A and 5B, it should be noted that, in other embodiments, three or more electrodes may be placed in parallel.

FIG. 5A further illustrates the treatment areas 423 and 427 associated with the anodes and the cathodes. Generally, each electrode of an anode pair or cathode pair may be at approximately the same potential and be placed in close proximity. Providing electrodes in parallel and in close proximity can ensure continued treatment even if one electrode has a high impedance due to local dehydration. More specifically, if one anode (or cathode) of an anode (or cathode) pair loses contact, the area will continue to be treated by the other anode (or cathode) in parallel. Additionally, arranging each electrode pair in parallel allows for each to be independently controlled. In other words, a power source, such as power source 202, may be used to deliver the current for each electrode pair in order to control the charge passing through each electrode and thus the size of the treatment zone. If multiple electrode pairs are placed on a single current source, the treatment zones may be controlled by putting a coulomb counter on each electrode and directing the desired amount of charge to each electrode.

The method of this embodiment will be explained with an example. Imagine that anode 1 422 has local desiccation and its impedance slowly rises. The circuitry will note that the voltage is increasing in pathway 1 (anode 1 to cathode 1) and thus diagnose a desiccation in that pathway. Circuitry must now determine which of the two electrodes is the culprit. A test “cross-current” is now passed from anode 1 to cathode 2. If this is passed with atypical voltage then it is verified that anode 1 is not the culprit and that cathode 1 is the problem. The output circuit is then reconfigured so that anode 1 is ignored and only anode 2 is used for current delivery while cathodes 1 and 2 are used in parallel for the return. In a similar manner, anode 1 will be tested for impedance every 1-10 seconds so it can be reused as soon as there is a re-infiltration of bodily fluids.

Note that during the temporary current delivery scheme of this embodiment, about ¾ of the tissue is still receiving DC ablation since three of the four electrodes are active.

Referring now back to FIG. 2, in operation, monitoring circuit 210 monitors the rate of change of voltage (dV/dt) of electrode load circuit 208 and prevents the voltage from rising in the event of a voltage spike in one embodiment. In other words, if dV/dt of the electrode load circuit is greater than a threshold level, a high impedance condition (i.e., bubble formation) is indicated and switching circuit 212 enables a discharge of the overload protection device 214, thereby limiting the voltage rise (dV/dt) at the output in relation to the discharge rate of the overload protection capacitor.

Various embodiments of systems, devices and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the invention. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the invention.

Persons of ordinary skill in the relevant arts will recognize that the invention may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the invention may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the invention can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted. Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended. Furthermore, it is intended also to include features of a claim in any other independent claim even if this claim is not directly made dependent to the independent claim.

Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

For purposes of interpreting the claims for the present invention, it is expressly intended that the provisions of Section 112(f) of 35 U.S.C. are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.

Claims (7)

The invention claimed is:

1. A direct current (DC) prostate ablation therapy system comprising:

a catheter including a plurality of electrodes configured to deliver a DC ablation therapy to prostate tissue;

a power source configured to supply a DC current to the plurality of electrodes;

an overload protection device configured to buffer energy from the power source;

a monitoring circuit configured to monitor a voltage of the DC ablation therapy;

a switching circuit configured to selectively control a path of the DC current from the power source to the plurality of electrodes and the overload protection device; and

a controller configured to selectively activate the switching circuit in response to the monitoring circuit detecting an undesirable increase in the voltage delivered for the DC ablation therapy.

2. The system of claim 1, wherein the power source is configured to selectively supply the DC current as a constant current of between 10 to 50 mA of direct current.

3. The system of claim 1, wherein the overload protection device comprises at least one capacitor.

4. The system of claim 1, wherein each of the plurality of electrodes comprises at least one anode and at least one cathode.

5. The system of claim 4, wherein each anode of each of the plurality of electrodes is electrically coupled to the power source via the switching circuit.

6. A direct current (DC) prostate ablation therapy system comprising:

a catheter including a plurality of electrodes configured to deliver a DC ablation therapy to prostate tissue;

a power source configured to supply a DC current to the plurality of electrodes;

an overload protection device configured to buffer energy from the power source;

a monitoring circuit configured to monitor an impedance of the DC ablation therapy;

a switching circuit configured to selectively control a path of the DC current from the power source to the plurality of electrodes and the overload protection device; and

a controller configured to selectively activate the switching circuit in response to the monitoring circuit detecting an undesirable change in the impedance for the DC ablation therapy.

7. A direct current (DC) prostate ablation therapy system comprising:

a catheter including a plurality of electrodes configured to deliver a DC ablation therapy to prostate tissue;

a power source configured to supply a DC current to the plurality of electrodes;

an overload protection device configured to buffer energy from the power source;

a monitoring circuit configured to monitor a parameter of the DC ablation therapy;

a switching circuit configured to selectively control a path of the DC current from the power source to the plurality of electrodes and the overload protection device; and

a controller configured to selectively activate the switching circuit in response to the monitoring circuit detecting a change in the parameter for the DC ablation therapy indicative of an undesirable increase in an energy being delivered by the DC ablation therapy.

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